eISSN: 1644-4124
ISSN: 1426-3912
Central European Journal of Immunology
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1/2022
vol. 47
 
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abstract:
Experimental immunology

Validation of the test for detecting SARS--CoV-2 antigens in the Polish population in patients with suspected SARS-CoV-2 infection

Mateusz Miłosz
1
,
Michał Słota
2
,
Jakub Jakubowski
3
,
Piotr Kwiatkowski
4
,
Sławomir Kasperczyk
4
,
Małgorzata Kozłowska
1
,
Barbara Pawłowska
1
,
Patryk Matuszek
1
,
Ewa Kuta
5

  1. EUROIMMUN Poland Sp. z o.o., Wrocław, Poland
  2. ARKOP Sp. z o.o., Bukowno, Poland
  3. Department of Cardiology, Electrotherapy and Angiology, SCANMED S.A. Raciborskie Centrum Medyczne, Racibórz, Poland
  4. Department of Biochemistry, Faculty of Medical Sciences in Zabrze, Medical University of Silesia in Katowice, Zabrze, Poland
  5. Center of Laboratory Diagnostic, Łódź, Poland
Cent Eur J Immunol 2022; 47 (1): 58-62
DOI: https://doi.org/10.5114/ceji.2022.113992
Online publish date: 2022/02/28
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In December 2019, the World Health Organization (WHO) reported that China had accumulated pneumonia of unclear etiology in Wuhan. According to WHO recommendations, in strictly defined situations, antigen tests can be implemented into the diagnostic algorithm to reduce the number of molecular tests performed and support the rapid identification and treatment of COVID-19 patients. According to WHO recommendations, the antigen test for diagnostic use should have a sensitivity of ≥ 80% and a specificity of ≥ 97% compared to molecular tests (NAAT). Based on the comparative analysis, the sensitivity and specificity of the SARS-CoV-2 Antigen ELISA test were determined concerning the RT-PCR reference method. The sensitivity of the SARS-CoV-2 Antigen ELISA was 100% (51/51) and the specificity was 98.84%. The obtained data demonstrate that the analyzed antigen test meets both the WHO and the Ministry of Health criteria.
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